Catalog Number

700036

Brand Name

Denticator

Version/Model Number

700036

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EAX

Product Code Name

MIRROR, MOUTH

Public Device Record Key

ee8703e7-9874-4b97-befd-35658af65f14

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

10302737000368

Quantity per Package

36

Contains DI Package

00302737000361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton